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HIV Infections clinical trials

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NCT ID: NCT00849680 Completed - HIV Infections Clinical Trials

A Study of Safety, Tolerability, and Immunogenicity of the MRKAd5 Gag/Pol/Nef Vaccine in Healthy Adults (V520-016)

Start date: April 2003
Phase: Phase 1
Study type: Interventional

The goal of this study is to understand the safety, tolerability and immunogenicity of the Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef Vaccine (MRKAd 5 HIV-1 gag/pol/nef) vaccine in healthy human volunteers compared to placebo. The study will also evaluate a number of dose levels and the necessity for and timing of booster injections.

NCT ID: NCT00849160 Completed - HIV Infections Clinical Trials

Study of Protease Inhibitor Regimen Switch in HIV-1 Infected Patients With Undetectable Viral Load to Prove the Non-inferiority of Once Daily Dose Regimen Versus the Current Twice Daily Regimen to Maintain the Viral Load Under the Limit of Detection.

RADAR
Start date: May 2009
Phase: Phase 3
Study type: Interventional

Darunavir boosted with ritonavir (darunavir/r) is a powerful protease inhibitor, able to reduce the viral load in patients infected with multi-resistant HIV strains; In vitro and in vivo studies have shown that the induction of resistance mutations in the protease gene is much more difficult with the association darunavir/r compared to the other ritonavir-boosted protease inhibitors (PI/r), testifying of a significantly higher genetic barrier to resistance. Moreover, the tolerance to darunavir is good, and the pharmacologic profile of this molecule allows a once daily administration with a 800/100 mg dose in patients infected with a wild HIV strain or with a slightly resistant to darunavir/r strain. Thus, we propose to evaluate the efficacy of the darunavir/r association once daily as a substitute to a protease inhibitor regimen administered twice daily in patients with undetectable viral load receiving a tritherapy including a protease inhibitor administered twice daily.

NCT ID: NCT00848211 Completed - HIV Infections Clinical Trials

Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects

THYMON-08001
Start date: February 2009
Phase: Phase 1/Phase 2
Study type: Interventional

This protocol represents the first in human study of TUTI-16, and is being conducted to establish the safety and human immunogenicity (anti-HIV-1 Tat titers) of subcutaneously administered TUTI-16. Activity of TUTI-16 will also be determined in minimizing HIV-1 viral loads and sustaining CD4+ T-cell levels.

NCT ID: NCT00846599 Completed - HIV Infections Clinical Trials

Postprandial Endothelial Dysfunction After a High-Fat Meal in HIV-infected Men

PERTH
Start date: January 2008
Phase: N/A
Study type: Observational

The purpose of this study is to examine the postprandial (anytime after a meal) effect of different dietary fats on endothelial function in HIV-infected and HIV-uninfected men.

NCT ID: NCT00845676 Completed - HIV Infections Clinical Trials

Treatment of Acute Hepatitis C Virus in HIV Co-Infection

Start date: March 2008
Phase: Phase 4
Study type: Interventional

This study is designed to test the hypothesis that treatment of hepatitis C virus (HCV) infection during the first 6 months after acquiring HCV among people who already have pre-existing HIV infection will result in improved responses to HCV therapy with a shorter duration of infection.

NCT ID: NCT00845013 Completed - HIV Infections Clinical Trials

Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension

Start date: November 2007
Phase:
Study type: Observational

The purpose of this study is to describe the epidemiology of pulmonary hypertension in individuals with HIV infection and to investigate its pathogenesis. We propose to conduct a prospective observational cohort study to determine the association between highly active antiretroviral therapy (HAART) and viral suppression in HIV-infected patients who have been identified to have pre-clinical pulmonary hypertension (Aim 1). In addition, we will investigate the mechanistic role of the HIV-1 Nef protein and HHV-8 infection in the development and progression of pulmonary hypertension in individuals with HIV (Aim 2). We will also investigate endothelial function in HIV-infected patients with pulmonary hypertension (Aim 3).

NCT ID: NCT00844519 Completed - HIV Infections Clinical Trials

Effect of Maraviroc on Endothelial Function in HIV-Infected Patients

Start date: January 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the potentially beneficial aspects of CCR5 inhibition on inflammation and endothelial function as measured by brachial artery reactivity in antiretroviral treated HIV patients with an undetectable viral load.

NCT ID: NCT00843713 Completed - HIV Infections Clinical Trials

Effect of Raltegravir on Endothelial Function in HIV-Infected Patients

Start date: January 2009
Phase: Phase 4
Study type: Interventional

Recent studies suggest that HIV patients are at increased risk for cardiovascular events; however, the mechanisms underlying this increased risk remain unclear. Our group was one of the first to demonstrate that HIV infection is independently associated with accelerated atherosclerosis, as measured by carotid artery-intima media thickness (IMT), and that HIV-associated inflammation may be driving this accelerated atherosclerosis. The mechanism by which HIV disease independent of any drug-specific toxicity increases the risk of cardiovascular disease during HAART is not known. We hypothesize that even well controlled HIV infection is independently associated with cardiovascular risk and that further decreasing HIV-associated inflammation adding newer antiretroviral agents will also decrease cardiovascular risk. We will perform a small clinical trial of approximately 50 HIV-infected patients each to study the relationship between HIV infection, inflammation, thrombosis, atherogenic lipoproteins, and measures of atherosclerosis. We propose the following specific aims: Aim 1: To determine the influence of traditional and novel markers of inflammation on endothelial function and IMT progression; Aim 2: To determine if "intensification" with raltegravir in subjects on long-term antiretroviral therapy with clinically undetectable HIV RNA levels will improve endothelial function, and to determine if this effect is mediated by alterations in inflammatory markers, lipoproteins and/or thrombotic factors. For Aim 2, subjects from 2 randomized, double-blind, placebo-controlled raltegravir intensification studies will be asked to co-enroll in this cardiovascular study.

NCT ID: NCT00842634 Completed - HIV Infections Clinical Trials

Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728 for HIV

Zinc-Finger
Start date: January 2009
Phase: Phase 1
Study type: Interventional

This research study is being carried out to study a new way to possibly treat HIV. This agent is called a "Zinc Finger Nuclease" or ZFN for short. ZFNs are proteins that can delete another protein named CCR5. This CCR5 protein is required for certain common types of HIV (CCR5 tropic) to enter into and infect T-cells. T-cells are one of the white blood cells used by the body to fight HIV. The most important T-cells are those called "CD4 T-cells." Some people are born without CCR5 on their T-cells. These people remain healthy and are resistant to infection with HIV. Other people have a low number of CCR5 on their T-cells, and their HIV disease is less severe and is slower to cause disease (AIDS). In order to delete the CCR5 protein on the T cells, this study will isolate large numbers of T-cells from subjects, and then deliver the ZFNs using a delivery vehicle called a viral vector. The viral vector used in this study is called an adenoviral vector. The vector is added to the cells at the beginning of the manufacture process and the ZFNs knock out the CCR5 protein. By the time T-cells are returned to subjects, there is minimal adenovirus or ZFN present. The removal of the CCR5 protein on the T-cells subjects receive, however, is permanent. The purpose of this research study is to find out whether "zinc finger" modified T-cells are 1. safe to give to humans and 2. find how "zinc finger" modified T cell affects HIV This is an experimental study. Laboratory studies have shown that when CD4 T-cells are modified with "zinc fingers", HIV is prevented from killing the CD4 T cells. On the basis of these laboratory results, there is the potential that "zinc fingers" may work in humans infected with HIV and improve their immune system by allowing their CD4 T-cells to survive longer (HIV usually kills T cells it infects). All subjects who receive ZFN Modified CD4+T cells will enroll in a Long Term, Follow-up study to monitor subjects. Subjects will be followed every 3 months for four years. If the ZFN Modified CD4+T cells are no longer found in the blood after four years, then subjects will be contacted yearly for the next 6 years. If the ZFN Modified CD4+T cells are found in the blood at year four, then the subjects will continue to be seen once a year until the ZFN Modified CD4+T cells are no longer found in the blood for a maximum of 10 years.

NCT ID: NCT00841711 Completed - HIV Infections Clinical Trials

Transitions: Linkages From Jail To Community

Start date: September 2008
Phase: N/A
Study type: Interventional

TRANSITIONS, a novel jail-release program for People Living with HIV/AIDS (PLWHA), will use evidence-based interventions and adapt them to create a comprehensive transitional program in Waterbury and New Haven County, Connecticut. Evidence-based interventions will include, but not be limited to, enhanced rapid HIV testing within the New Haven Community Correctional Center (NHCCC, local jail), intensive case management, continuity of buprenorphine treatment from the jail to the community setting and a novel Money Management (MM) program. The HIV in Prisons Program and the Community Health Care Van (CHCV) at the Yale University AIDS Program, in collaboration with the Connecticut Department of Correction and the Waterbury Hospital Infectious Diseases Clinic, propose to expand the availability of opiate substitution treatment and to enhance clinical and social services for PLWHA, who are transitioning from the jail to the community setting. As part of Transitions, we will develop a model Money Management program that we have used in community settings to improve health outcomes for socially and medically marginalized populations and adapt it for a jail-release program. The Transitions program will incorporate these elements into a combined intervention and will result in a clinical trial to compare the additional contribution of a money management program.